A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal‐bolus insulin or a glucagon‐like peptide‐1 receptor agonist plus basal insulin: The SIMPLE study

Autor: Muhammad S. Siddiqui, Ildiko Lingvay, Uma Gunasekaran, Laurentiu M. Pop, Katherine Peicher, Ahmed Elhassan, Marconi Abreu, Luigi F. Meneghini, Xilong Li, Beverley Adams-Huet, Olivia Papacostea, Anna Tumyan, Perihan Dimachkie
Rok vydání: 2019
Předmět:
Adult
Blood Glucose
Male
Agonist
Comparative Effectiveness Research
medicine.medical_specialty
medicine.drug_class
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
030209 endocrinology & metabolism
Type 2 diabetes
030204 cardiovascular system & hematology
Gastroenterology
law.invention
03 medical and health sciences
0302 clinical medicine
Endocrinology
Insulin Detemir
Randomized controlled trial
Glucagon-Like Peptide 1
law
Internal medicine
Internal Medicine
medicine
Clinical endpoint
Humans
Hypoglycemic Agents
Meals
Insulin Aspart
Glucagon-like peptide 1 receptor
Glycated Hemoglobin
business.industry
Liraglutide
Insulin
Body Weight
Middle Aged
medicine.disease
Hypoglycemia
Treatment Outcome
Diabetes Mellitus
Type 2
Drug Therapy
Combination
Female
business
Body mass index
medicine.drug
Zdroj: Diabetes, Obesity and Metabolism. 21:2133-2141
ISSN: 1463-1326
1462-8902
DOI: 10.1111/dom.13794
Popis: Aim To compare the efficacy and safety of a glucagon-like peptide-1 receptor agonist (GLP1RA) plus basal insulin versus basal-bolus insulin treatment in patients with very uncontrolled type 2 diabetes. Materials and methods The SIMPLE study was a 6-month pragmatic, randomized, open-label trial testing the effectiveness of two approaches to treat patients with type 2 diabetes and HbA1c ≥10%. We randomized patients to detemir plus liraglutide or detemir plus aspart (before each meal). The primary endpoint was change in HbA1c; changes in body weight, insulin dose, hypoglycaemia and diabetes-related quality-of-life were secondary outcomes. Results We randomized 120 participants aged 47.4 ± 9.5 years, Hispanic 40%, African American 42%, diabetes duration 10 [25th-75th percentile (6 to 15)] years, body mass index 37.2 ± 10.3 kg/m2 . HbA1c decreased more with GLP1RA plus basal insulin [12.2% (95% CI 11.8% to 12.6%) to 8.1% (95% CI 7.4% to 8.7%)] compared with basal-bolus insulin [11.8% (95% CI 11.5% to 12.2%) to 8.8% (95% CI 88.1% to 9.55%)]; estimated treatment difference (ETD) of -1.1% (95% CI -2.0% to -0.1%) (non-inferiority margin 0.4% and P = .0001, superiority P = .026). Compared with basal-bolus insulin, treatment with GLP1RA plus basal insulin led to a body weight ETD of -3.7 kg (95% CI -5.8 to -1.5; P = .001), fewer patients experiencing hypoglycaemia [66.1% vs 35.2% (P = .002)], and greater improvements in general/current health perception, treatment satisfaction, and fear of hypoglycaemia, while taking a lower total daily dose of insulin [estimated treatment ratio 0.68 (95% CI 0.55 to 0.84)]. Conclusions In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life. This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen.
Databáze: OpenAIRE
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